(48 days)
The OPTIS Integrated System with C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The C7 Dragonfly, Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The C7 Dragonfly DUO, or Dragonfly OPTIS Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.
The OPTIS Integrated System will further acquire radio frequency signal outputs from both a distal intracoronary pressure transducer and a proximal aortic pressure transducer to determine the physiological parameter. Fractional Flow Reserve (FFR). The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated.
The OPTIS Integrated System performs optical coherence topography (OCT) and fractional flow reserve (FFR) procedures and provides images of the coronary arteries in patients who are candidates for transluminal interventional procedures. The device utilizes fiber-optic technology to emit near infrared light and receive light reflected from coronary tissue in order to produce high resolution, real time images. The imaging engine generates wavelength scanning light, which is guided to the DOC and the catheter. The reflection is collected and sent back to the engine. The engine processes the optical signal and converts it to electrical signal, which is then fed into the Host PC. The software application processes the signal and generates OCT images. The devices is compatible with Dragonfly OPTIS, Duo, and I imaging catheters, in addition to the PressureWire Aeris.
The Dragonfly OPTIS Imaging Catheter is a sterile, single-use intravascular catheter consisting of a catheter body external sheath and an internal rotating fiber optic imaging core. The external sheath serves two primary functions: 1) to facilitate placement of the device into the coronary artery and 2) to cover and protect the inner rotating fiber optic imaging core.
The inner rotating fiber optic imaging core emits near infrared light to the tissue and receives reflected light. It is driven by a stainless steel torque wire visible under fluoroscopy and pulled back through the window tube of the external sheath by the DOC. The emitted and returned reflected light are combined and processed by the OPTIS Integrated System software to construct an OCT image. The patient is never exposed to moving parts as the external sheath completely covers the rotating imaging core.
This document is a 510(k) summary for a medical device and thus does not contain the detailed acceptance criteria or a comprehensive study report with all the requested information for device performance. It primarily focuses on demonstrating substantial equivalence to a predicate device.
However, based on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific quantitative thresholds nor directly report device performance against such criteria in a comparative table. Instead, it states that "Design verification and validation was also performed on the OPTIS Integrated System and Dragonfly OPTIS Imaging Catheter in compliance with internal design control procedures which included bench testing and pre-clinical animal testing. The results of this testing concludes the OPTIS Integrated System and Dragonfly OPTIS Imaging Catheter is determined to be safe and effective and is substantially equivalent to the ILUMIEN OPTIS predicate device."
This implies that the acceptance criteria were likely based on demonstrating equivalence to the predicate device's performance, as well as adherence to various safety and performance standards (e.g., IEC 60601 series for electrical safety, electromagnetic compatibility, and usability, and 21 CFR 1040.10 for light-emitting products). The performance reporting is qualitative, stating that the device is "safe and effective."
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "pre-clinical animal testing" but does not specify the sample size for this test set (e.g., number of animals, number of imaging procedures). It also does not provide the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. The document focuses on showing substantial equivalence through design verification and validation, including bench and pre-clinical animal testing.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is an imaging system (OCT and FFR), which inherently involves a human operator (physician) for interpretation and clinical decision-making. The document does not describe an "algorithm only" standalone performance study in the way one might for an AI diagnostic tool. Its performance would be evaluated in terms of image quality, FFR measurement accuracy, and overall system functionality as used by a human.
7. Type of Ground Truth Used
The document doesn't explicitly state the "type of ground truth" used for the pre-clinical animal testing. For imaging systems, ground truth in animal studies often involves:
- Histopathology: Microscopic examination of tissue samples after imaging to correlate image findings with actual tissue structures.
- Other established imaging modalities: Comparison with a gold standard imaging technique if available for the specific features being evaluated.
- Direct observation/measurement: For functional parameters like FFR, comparison against direct pressure measurements.
Given the nature of OCT imaging for coronary arteries, histopathology or highly detailed anatomical measurements would likely be involved. For FFR, direct pressure transducer measurements during the animal study would serve as ground truth.
8. Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning or AI. While the device uses software, the context here is a medical imaging system, not a deep learning algorithm that typically requires a large training dataset. The software upgrades mentioned (e.g., Angio Co-Registration, Continuous calibration, improved acquisition workflow) likely involve traditional software engineering and validation processes rather than machine learning model training.
9. How the Ground Truth for the Training Set Was Established
As no training set (in the AI/ML sense) is mentioned, this information is not applicable or provided. The software validation would have involved testing against requirements and specifications, rather than a "ground truth" derived from a large dataset for training.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).